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U.S. Department of Health and Human Services

Class 2 Device Recall IMRIS ORT100 and ORT 200

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  Class 2 Device Recall IMRIS ORT100 and ORT 200 see related information
Date Initiated by Firm October 19, 2012
Date Posting Updated November 21, 2012
Recall Status1 Terminated 3 on December 11, 2012
Recall Number Z-0428-2013
Recall Event ID 63500
510(K)Number K061916  K071099  K083137  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
Code Information 10002845, 10002341, 10003244, 10002794, 10003243, 10003629, 10003801, 10002654, 10002796, 10002795, 10002846, 10002847, 10003830, 10003064, 10005201,10003754, 10004513

Recalling Firm/
Innovative Magnetic Resonance Imaging Systems Inc.
78 Innovation Drive
Winnipeg Canada Manitoba
Manufacturer Reason
for Recall
IMRIS Inc. initiated a recall of their OR Tables ORT100 and ORT200. When proper procedure is not followed, the foot end of the IMRIS intra-operative OR table may be attracted to the MRI magnet as the magnet approaches the table. This poses a potential risk of injury to both the patient and operators standing near the table.
FDA Determined
Cause 2
Labeling design
Action Consignees were sent on 10/19/12 a IMRIS "Urgent Medical Device Correction" letter dated October 16. 2012. The letter described the product and the problem involved in the recall. It also provided changes to the Operator's Manual and labeling which addresses the issue. Customers may contact 1-866-475-0525.
Quantity in Commerce 23
Distribution Nationwide Distribution, including the states of FL, GA, IN, MD,MA, MI, MN, MO, TN, UT, and VA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = IMRIS, INC.